Status:
ACTIVE_NOT_RECRUITING
Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy
Lead Sponsor:
Outcomes'10
Conditions:
Anticoagulated Patients
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This study is designed to find out if it is safe to keep taking blood-thinning medicine during the removal of polyps from the colon or rectum. It includes patients who regularly take blood thinners a...
Detailed Description
This multicenter, phase IV, assessor-blinded, non-inferiority clinical trial evaluates the safety of maintaining oral anticoagulant therapy during colorectal polypectomy. The study population includes...
Eligibility Criteria
Inclusion
- Age over 18 years.
- Patients scheduled for elective outpatient colonoscopy for any indication, in whom removal of colorectal polyps will be performed if identified during the procedure.
- Anticoagulant treatment with vitamin K antagonists (acenocoumarol or warfarin) or direct oral anticoagulants (dabigatran, edoxaban, apixaban, or rivaroxaban) prior to the colonoscopy.
Exclusion
- Concomitant antiplatelet therapy.
- Age over 85 years.
- Urgent colonoscopy.
- Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs.
- Supratherapeutic INR (\>3.5) at the time of the procedure in patients on VKAs.
- Pregnancy.
- Decompensated liver cirrhosis.
- Inability, at the investigator's discretion, to understand the periprocedural anticoagulation regimen.
- Known coagulopathy or bleeding diathesis, including platelet count \<50,000/µl in the previous 12 months.
- Scheduled endoscopic dilation.
- Severe psychiatric disorder.
- Removal of colorectal lesions by endoscopic submucosal dissection.
- Previous diagnosis of renal failure defined as creatinine \>2 mg/dl or clearance \<30 ml/min.
- Planned high bleeding risk procedure during simultaneous gastroscopy.
- Previous inclusion in the trial. Patients may only be included once.
- Patients who are not candidates for a second endoscopic intervention due to clinical conditions.
- Any clinical situation or concomitant treatment that, in the investigator's opinion, poses a significant bleeding risk.
- Patients with polyps larger than 4 cm pending endoscopic resection.
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT07185295
Start Date
October 18 2024
End Date
December 30 2026
Last Update
November 24 2025
Active Locations (10)
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1
Clínica Rotger Quirónsalud
Palma, Balearic Islands, Spain, 07012
2
Servicio de Aparato Digestivo. Hospital Sierrallana. Barrio Ganzo,
Torrelavega, Cantabria, Spain, 39300
3
Servicio de Gastroenterología y Hepatología. Hospital Universitario Río Hortega.
Valladolid, Castille and León, Spain, 47012
4
Servicio de Digestología, Hospital del Mar. Instituto Hospital del Mar de Investigaciones Médicas.
Barcelona, Catalonia, Spain, 08003